MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ACAPELLA DUET VIBRATORY PEP THERAPY SYSTEM; SPIROMETER, THERAPEUTIC (INCENTIVE)

Model Number	27-9000
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was inner packing defect on the item.No additional information.

• Brand Name: PORTEX ACAPELLA DUET VIBRATORY PEP THERAPY SYSTEM
• Common Device Name: SPIROMETER, THERAPEUTIC (INCENTIVE)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14043264
• Report Number: 3012307300-2022-05956
• Device Sequence Number: 17383666
• Product Code: BWF
• UDI-Device Identifier: 10788942290006
• UDI-Public: 10788942290006
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K002768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/30/2026
• Device Model Number: 27-9000
• Device Catalogue Number: 27-9000
• Device Lot Number: 4125195
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown